Renocel 2000IU

Red blood cells are originated in the bone marrow. To make red blood cells, the body regulate a sufficient supply of erythropoietin (EPO), a hormone which is formed by the kidney. It helps to make red blood cells.
When have more red blood cells increases the haemoglobin levels. Haemoglobin is the protein in red blood cells which is needed for blood carry oxygen throughout the body.
Anaemia is a disorder which arise when there is not sufficient haemoglobin in a person's blood. There are different causes of anaemia. For instance, Anemia can be caused by the body's impotence to produce sufficient EPO to make red blood cells.
In case, the person may have to undergo blood transfusion to cure this type of anaemia. If you have anaemia, your physician can determine the cause.

Erythropoietin

Renocel

2000IU

Intas

INDICATION OF Renocel 2000IU INJECTION

Renocel 2000IU injection is indicated for the treatment of following conditions
Anemia due to chronic kidney disease including patients on dialysis or without dialysis to reduce the requirement of RBC transfusion
Anemia due to Zidovudine given ≤ 4200 mg/week in HIV infection patients with levels of erythropoietin endogenous serum of ≤munits/mL.

Anemia due to effect of concomitant myelosuppressive chemotherapy
Renocel 2000IU is indicated to decrease the uses for allogeneic RBC transfusions among patients with perioperative haemoglobin > 10 to ≤ 13 g/dL who are at serious risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. Renocel 2000IU is not used for patients who are willing to donate autologous blood pre-operatively.

PHARMACOLOGICAL ACTION OF Renocel 2000IU INJECTION

Erythropoietin controls erythropoiesis by stimulating the differentiation and replication of erythroid precursors, stimulating the release of reticulocytes into the circulation, and synthesis of cellular haemoglobin.

Recombinant human erythropoietin is available as epoetin alfa and epoetin beta which are required in the management of anaemia’s along with CRF, cancer chemotherapy and anti-aids drug zidovudine.

Pharmacokinetic

Time to peak plasma concentration of Renocel 2000IU is 20 to 25 hours and bioavailability of SC injectable Renocel 2000IU is much lower than IV injection and is 20-24%.
Adult and paediatric with CRF peak plasma level is 5 to 24 hours

Bounding of erythropoietin and epoetin alfa to EPO-R causes to cellular internalization, which includes the degradation of the ligand. Erythropoietin and epoetin alfa may also be disgraced by the reticuloendothelial scavenging pathway or lymphatic system

Renocel 2000IU injection are cleared through uptake and degradation via the EPO-R-expressing cells and may also involve other cellular pathways in the interstitium. Only a little amount of unchanged epoetin alfa is found in the urine.
Half-life in adult is 4 hours and for children is approx. 6 hours
Adult and paediatric with CRF the half-life is 4 to 13 hours

Important Dosing Information
Administer Evaluation of Iron Stores and Nutritional Factors
Monitoring of Response to Therapy in Anemia
Formulation Based Selection In pregnant women, lactating women, neonates, and infants use only single-dose vials (the benzyl alcohol-free formulation)

Patients with Chronic Kidney Disease
For all patients with CKD:
When starting or adjusting therapy, monitor haemoglobin levels at least weekly until stable, then monitor at least monthly.
Avoid rises of the dose more frequently than once every 4 weeks. Reduces in dose can occur more frequently. Avoid frequent dose adjustments.
If the haemoglobin increases rapidly, decrease the dose of Renocel by 25% or more as required to reduce fast responses.

For adult patients with CKD on dialysis
Start Renocel therapy when the haemoglobin level is less than 10 g/dL.
If the haemoglobin level approaches or exceeds 11 g/dL, decrease the dose of Renocel.
The usual starting dose for adult patients is 50 to 100 Units/kg 3 times weekly IV or SC. The intravenous route is prescribed for patients on haemodialysis.

For paediatric patients with CKD
Start Renocel therapy only when the haemoglobin level is less than 10 g/dL.
If the haemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Renocel.
The usual starting dose for paediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly intravenously or subcutaneously.

Zidovudine-treated Patients with HIV-infection
Starting Dose
The prescribed initial dose in adults is 100 Units/kg as an IV or SC injection 3 times per week.
Discontinue Renocel if an increase in haemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.

Patients on Cancer Chemotherapy
Start Renocel in patients on cancer chemotherapy only if the haemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.
Use the less dose of RENOCEL needed to avoid RBC transfusions.
Usually Starting Dose
For Adults administer the dose of 150 Units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 Units subcutaneously weekly until completion of a chemotherapy course.
Paediatric Patients (5 to 18 years): 600 Units/kg intravenously weekly until completion of a chemotherapy course.

Surgery Patients
The prescribed Renocel injections are:
300 Units/kg per day subcutaneously (SC) for 15 days total: given daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery.
600 Units/kg subcutaneously (SC) in 4 doses given the patients 21, 14, and 7 days before surgery and on the day of surgery.

Over dosage

Renocel 2000IU overdose can cause by above the desired level of haemoglobin levels, which must be controlled with discontinuation or reduction of Renocel 2000IU dosage with phlebotomy.

Cancer patients will Increased tumor development rate when dosed to achieve haemoglobin level of >12 mg/ld.

In Chronic renal failure patients at starting of treatment, transferrin saturation should be ≥20% and ferritin ≥100 ng/mL

Patients go through surgery are at high risk for DVT; concomitant DVT prophylaxis is strongly recommended
In Zidovudine-treated patients may have response only when zidovudine dosage <4200 mg/wk and endogenous epoetin <500 U/mL

In Dialysis patients having IV administration recommended to decrease red-cell aplasia risk; rises anticoagulation with heparin may be needed to prohibit clotting of extracorporeal circuit during haemodialysis

Contraindications

The limited available data on pregnancy women have insufficient to describe a drug associated risk of adverse development outcomes.
Renocel 2000IU from multiple dose which contains benzyl alcohol is contraindicated to pregnant women.
If pregnant women needed treatment with Renocel 2000IU then use benzyl alcohol free formulation to avoid harm to foetus.

Renocel 2000IU from multiple dose which contains benzyl alcohol is contraindicated to lactating women
Advise the breast-feeding women not to feed for at least 2 weeks after the last dose.
Possible similar harm to infants exposed to benzyl alcohol through human milk.

If dose is missed then immediately take the dose you remember before next dose otherwise skip the missed, if next dose time reached. Do not take extra dose at a time. Take advice of the doctor about missed dose

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